The assessment of patient reported outcomes and health-related quality of life
continue to be rapidly evolving areas of research and this new edition reflects
the development within the field from an emerging subject to one that is an
essential part of the assessment of clinical trials and other clinical studies.
This book is aimed at everyone involved in quality-of-life research and is applicable to medical and non-medical, statistical and non-statistical readers. It is of particular relevance for clinical and biomedical researchers within both the pharmaceutical industry and clinical
The analysis and interpretation of quality-of-life assessments relies on a variety of psychometric and statistical methods which are explained in this book in a non-technical way. The result is a practical guide that covers a wide range of methods and emphasizes the use of simple techniques that are illustrated with numerous examples, with extensive chapters covering qualitative and quantitative methods and the impact of guidelines. The material in this new third edition reflects current teaching methods and content widened to address continuing developments in item response theory, computer adaptive testing, analyses with missing data, analysis of ordinal data, systematic reviews and meta-analysis.
Preface to the third edition
Preface to the second edition
Preface to the first edition
List of Abbreviations
Part One: Developing and validating instruments for assessing Quality of Life and Patient-Reported Outcomes.
2 Principles of measurement scales
3 Developing a questionnaire
4 Scores and measurement: validity, reliability, sensibility
5 Multi-item scales
6 Factor analysis and structural equation modeling
7 Item response theory and differential item functioning
8 Item banks, item linking and computer-adaptive tests
Part 2: Assessing, analysing and reporting Patient-Reported Outcomes and the Quality of Life of patients.
9 Choosing and scoring questionnaires
10 Clinical trials
11 Samples sizes
12 Cross-sectional analysis
13 Exploring longitudinal data
14 Modelling longitudinal data
15 Missing data
16 Practical and reporting issues
17 Death and Quality-adjusted survival
18 Clinical interpretation
19 Biased reporting and response shift
Appendix – Examples of Instruments
Appendix – Statistical tables
Appendix – References